Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

Not Applicable

Recruiting

• Conditions: Acute Pain; Postoperative Analgesia; Thoracic Paravertebral Block; Thoracotomy; Local Anesthetic
• Interventions: Procedure: TPVB with 25 ml; Procedure: TPVB with 20 ml; Procedure: TPVB with 30 ml

• Registration Number: NCT05700357
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Thoracic epidural analgesia (TEA) is the gold standard method in the treatment of pain after thoracotomy. Thoracic paravertebral block (TPVB) is known as the most effective method after TEA. The fact that TPVB has fewer side effects than TEA increases the use of TPVB. There is no consensus on the dose of analgesia in studies. In the literature, volumes between 20 ml and 30 ml are frequently used for TPVB in recent years. This study, it was aimed to compare the efficacy of 20 ml, 25 ml, and 30 ml volumes of TPVB with local anesthetic at the same concentration (0.25% bupivacaine) on postoperative analgesia in patients undergoing thoracotomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-28
• Study First Submitted: 2023-01-07
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-11-28
• Study Completion: 2024-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 18 to 80 years old
• American Society of Anesthesiologists (ASA) physical status I-II-III
• BMI 18 to 40 kg/m2
• Elective thoracotomy surgery

Exclusion Criteria

• Patient refusing the procedure
• Emergency surgery
• History of chronic opioid or analgesic used

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic Paravertebral Block 25 ml	TPVB with 25 ml	In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 25 ml of 0.25% bupivacaine will be injected into this area.
Thoracic Paravertebral Block 20 ml	TPVB with 20 ml	In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.
Thoracic Paravertebral Block 30 ml	TPVB with 30 ml	In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

Primary Outcome Measures

Name	Time	Method
Pain Scores	48th-hour after surgery.	Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Secondary Outcome Measures

Name	Time	Method
Morphine Consumption	24 hours after surgery	Morphine consumption for 24 hours will be recorded

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Çankaya, Ankara, Turkey